Aphexda

— THERAPEUTIC CATEGORIES —
  • Miscellaneous hematological agents
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Aphexda Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Motixafortide 62mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free.

    Pharmacological Class

    Hematopoietic stem cell mobilizer.

    How Supplied

    Single-dose vial (1.7mL)—1

    Storage

    Store at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Discard prepared reconstituted solution after 24 hours storage under refrigeration 2°C to 8°C (36°F to 46°F) or at room temperature 20°C to 25°C (68°F to 77°F) protected from light.

    Manufacturer

    BioLineRx USA Inc.

    Generic Availability

    NO

    Mechanism of Action

    Motixafortide is an inhibitor of the C-X-C Motif Chemokine Receptor 4 (CXCR4) and blocks binding of its cognate ligand, stromal derived factor-1α (SDF-1α)/CXCL12. Treatment with motixafortide resulted in leukocytosis and elevations in circulating hematopoietic stem and progenitor cells in mice, dogs and humans. Stem cells mobilized by motixafortide were capable of engraftment with long-term repopulating capacity in a rodent transplantation model. 

    Aphexda Indications

    Indications

    In combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

    Aphexda Dosage and Administration

    Adult

    Premedicate with diphenhydramine (IV or oral), H2 blocker (eg, famotidine), a leukotriene inhibitor (eg, montelukast) approx. 30–60mins before each dose; plus APAP. Start filgrastim for 4 days prior to Aphexda and on each day prior to each apheresis. Base dose on actual body weight. Give 1.25mg/kg by slow SC inj (~2 mins) into abdomen, upper arms, or thighs at 10–14hrs prior to the first apheresis; may give a second dose 10–14hrs before a third apheresis if needed. Rotate inj sites.

    Children

    Not established.

    Administration

    Administer via slow (approximately 2 minutes) subcutaneous injection into the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. 

    Avoid injection sites into scar tissue or areas that are reddened, inflamed, or swollen. If more than one injection is needed for a single dose of Aphexda, the injection sites should be at least 2cm apart from previous injection locations.

    Monitor patients for 1 hour after administration.

    Aphexda Contraindications

    Not Applicable

    Aphexda Boxed Warnings

    Not Applicable

    Aphexda Warnings/Precautions

    Warnings/Precautions

    Not for use in leukemia. May cause mobilization of tumor cells (in combination with filgrastim). Monitor for signs of hypersensitivity during and after administration for at least 1hr. Have anaphylactic treatment readily available. Monitor WBCs during treatment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 8 days after last dose. Pregnancy: avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 8 days after last dose).

    Pregnancy Considerations

    Risk Summary

    • May cause fetal harm. There are no available data with Aphexda use in pregnant women informing the risk of embryo-fetal toxicity.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production.

    • Do not breastfeed during treatment and for 8 days after the final dose.

    Pediatric Considerations

    Safety and efficacy have not been established in pediatric patients.

    Other Considerations for Specific Populations

    Females and Males of Reproductive Potential

    • Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiation.

    • Contraception: May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 8 days after the final dose.

    Aphexda Pharmacokinetics

    Absorption

    Time to maximum concentration: ~0.25–1.17 hours.

    Distribution

    Volume of distribution of the central compartment: ~27 L. Plasma protein bound: >99%.

    Metabolism

    Catabolic pathways.

    Elimination

    Renal (~80–82%). Half-life: ~2 hours. Apparent total clearance: 46.5 L/h.

    Aphexda Interactions

    Not Applicable

    Aphexda Adverse Reactions

    Adverse Reactions

    Inj site reactions (eg, pain, erythema, pruritus), pruritus, flushing, back pain; hypersensitivity reactions, tumor cell mobilization, leukocytosis.

    Aphexda Clinical Trials

    Clinical Trials

    The approval was based on data from the phase 3 GENESIS study (ClinicalTrials.gov Identifier: NCT03246529), which assessed the efficacy and safety of motixafortide plus G-CSF for the mobilization of hematopoietic stem cells in 122 adults with multiple myeloma. Study participants were randomly assigned 2:1 to receive either motixafortide 1.25mg/kg subcutaneously (n=80) or placebo plus G-CSF (n=42). Prior to treatment, patients received daily morning doses of filgrastim for 4 days. 

    Findings showed that 67.5% of patients in the motixafortide treatment arm met the primary endpoint achieving the cell collection goal of at least 6.0 x 106 CD34+ cells/kg in up to 2 apheresis sessions after a single administration vs 9.5% of those in the placebo arm (adjusted difference of 56.8%; P <.0001). 

    Additionally, a greater proportion of patients treated with motixafortide achieved a cell collection goal of ≥6.0 x 106 CD34+ cells/kg in 1 apheresis session (63.8% vs 2.4% for placebo; P <.0001) and a cell collection goal of ≥2.0 x 106 CD34+ cells/kg in 1 apheresis session (87.5% vs 38.1% for placebo; P <.0001). The time to neutrophil and platelet engraftment and graft durability after transplantation were similar across treatment arms.

    Aphexda Note

    Not Applicable

    Aphexda Patient Counseling

    Patient Counseling

    Advise patients regarding the risk of anaphylactic and hypersensitivity reactions (eg, pruritus, flushing, urticaria, rash, vomiting, nausea, and chills) during and after Aphexda injection and to immediately report if any signs and symptoms develop to their health care professional.

    Advise patients that injection site reactions may occur (eg, pain, redness, and swelling).

    Advise females of reproductive potential to use effective contraceptive methods during treatment and for 8 days after administration.

    Advise females of reproductive potential to contact their health care provider if they become pregnant or if pregnancy is suspected during treatment.

    Advise women to not breastfeed during treatment and for 8 days after the last dose.

    Cost Savings Program

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